Pressure based refill status monitor for implantable pumps

ABSTRACT

The present invention includes systems and methods for detecting fluid flow into or out of a port chamber or a reservoir of an implantable medical device utilizing a pressure sensor and calculating the fluid status of the reservoir. The system detects characteristic pressure profiles associated with fluid flowing into the medical device, out of the medical device, and also whether one or both of the port chamber or reservoir are substantially empty or substantially full. In addition, the present invention may generate a sensory cue to a clinician to indicate the fluid status.

RELATED APPLICATION

This application claims the benefit of the filing date of a provisionalU.S. Application Ser. No. 61/116,309, filed Nov. 20, 2008.

FIELD

The present invention relates to implantable medical devices fordelivering fluid to a target site within a patient. More particularly,it relates to systems, devices and methods for sensing and monitoringthe withdrawal and filling of fluid into a reservoir of the medicaldevice and estimating the fluid volume present in the reservoir.

BACKGROUND

A variety of implantable infusion devices are available for treatingpatients. For example, implantable infusion devices are used fordelivering therapeutic substances to a target location of a patient. Theimplantable infusion devices are implanted subcutaneously in aconvenient location in the patient. An infusion catheter is connected toan outlet of the device and positioned in the patient to allow deliveryto the target location. A therapeutic substance may then be introducedpercutaneously into a reservoir of the implanted device by inserting aneedle into a port assembly of the device and delivering a fluidcontaining the therapeutic substance to the device via the needle.

Because the device is implanted within the patient and cannot be seendirectly, care must be taken to monitor the withdrawal and filling ofthe therapeutic substance into the reservoir. For example, when removinga drug from the reservoir it is advantageous to know when the all orsubstantially all of the drug has been removed. Moreover, it isadditionally advantageous to know when the reservoir has been filledwith the new drug. Commercially available sensors that indicate theamount of fluid in the reservoir are not ideal due to size and spacelimitations. Such sensors may include a float connected to a variableresistor, a pressure sensor, sometimes connected to a mercury manometer,or low voltage capacitors where the fluid can go between them toregister a reading.

A need therefore exists for a system capable of detecting the flow oftherapeutic substance out of and into the reservoir of an implantabledelivery device. A need also exists for indicating a reasonableapproximation of how full the reservoir is during filling emptying andpumping procedures.

SUMMARY

The present disclosure describes, inter alia, systems, devices andmethods that can be used to monitor the flow of a therapeutic substance,or other material such as a wash or rinse aid, into the reservoir of animplantable infusion device. The methods, systems and devices may beused to detect the flow into and out of the reservoir of the implantableinfusion device. Moreover, the methods, systems and devices may be ableto indicate a fill status, i.e., how full or empty the reservoir is,during filling and emptying procedures.

Another embodiment is a method for calculating the fill status of areservoir in an implantable medical device, the steps including sensinga pressure differential between the reservoir and a fill port using apressure sensor, calculating the fluid rate at which fluid is added toor removed from the reservoir based upon pressure differential and aknown fluidic restriction constant for the medical device, determiningthe total volume of fluid added to or removed from the reservoir byintegrating the fluid rate over the in which the sensed pressure changeis detected, and combining the fluid volume added to or removed from thereservoir with the known starting volume of the reservoir to determinethe fill status.

Another embodiment is a method for displaying a fluid status of thereservoir of an implantable medical device including calculating thefluid status by sensing a pressure differential between the reservoirand a fill port using a pressure sensor, calculating the fluid rate atwhich fluid is added to or removed from the reservoir based uponpressure differential and a known fluidic restriction constant for themedical device, determining the total volume of fluid added to orremoved from the reservoir by integrating the fluid rate over the inwhich the sensed pressure change is detected, and combining the fluidvolume added to or removed from the reservoir with the known startingvolume of the reservoir to determine the fill status, and displaying thecalculated fluid status on a programmer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic representation of a perspective view of animplantable infusion system implanted in a patient.

FIGS. 2-8 are block diagrams depicting implantable infusion systems orcomponents thereof in accordance with principles of the presentinvention.

FIG. 9 is a cross-sectional view of a portion of an implantable infusiondevice useful with the systems of FIGS. 2-8.

FIG. 10 is a graph of pressure over time as monitored in a reservoir ofan implantable infusion device during the emptying and filling of thereservoir.

FIGS. 11-18 are illustrations of example screen shots that can be usedto report the fill status of the reservoir and related information.

FIG. 19 is a graph showing the ideal pressure in a reservoir dependingon the fill status.

FIG. 20 is a chart showing reservoir fill status, or the estimatedreservoir fluid volume, versus time during a refill operation.

FIG. 21 is a flow diagram showing the steps of one embodiment of thepresent invention.

The drawings are not necessarily to scale. Like numbers used in thefigures refer to like components, steps and the like. However, it willbe understood that the use of a number to refer to a component in agiven figure is not intended to limit the component in another figurelabeled with the same number.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof, and in which are shown byway of illustration several specific embodiments of devices, systems andmethods. It is to be understood that other embodiments are contemplatedand may be made without departing from the scope or spirit of thepresent invention. The following detailed description, therefore, is notto be taken in a limiting sense.

All scientific and technical terms used herein have meanings commonlyused in the art unless otherwise specified. The definitions providedherein are to facilitate understanding of certain terms used frequentlyherein and are not meant to limit the scope of the present disclosure.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” encompass embodiments having pluralreferents, unless the content clearly dictates otherwise. As used inthis specification and the appended claims, the term “or” is generallyemployed in its sense including “and/or” unless the content clearlydictates otherwise.

As used herein, “sensory cue” means a cue capable of being received by aperson, such as an audible, tactile, or visual cue. A visual cue mayinclude, for example, text or an image.

Unless otherwise indicated, all numbers expressing feature sizes,amounts, and physical properties used in the specification and claimsare to be understood as being modified in all instances by the term“about.” Accordingly, unless indicated to the contrary, the numericalparameters set forth in the foregoing specification and attached claimsare approximations that can vary depending upon the desired propertiessought to be obtained by those skilled in the art utilizing theteachings disclosed herein.

The recitation of numerical ranges by endpoints includes all numberssubsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3,3.80, 4.0, and 5.0) and any range within that range.

The present disclosure describes, inter alia, systems, devices andmethods that can be used to detect the fluid status of a reservoirduring withdrawal and/or filling of fluid into a reservoir in animplantable medical device. The systems, devices and methods cancalculate a reasonable approximation of the fill status of the reservoirand report that status to a user through a display or other means. Asdiscussed herein, it has been discovered that a decrease in pressure canbe detected when the therapeutic substance, or other material such as awash or rinse aid, (collectively “material” or “fluid”), is beingwithdrawn from the reservoir or has been completely withdrawn using aneedle or other device that accesses a port chamber. It has also bediscovered that an increase in pressure can be detected when thereservoir is being filled or when the chamber becomes fully orsubstantially filled. The decrease in pressure or the increase inpressure can be used to approximate a rate at which the reservoir isbeing emptied or filled. From that approximation a fill status can bedisplayed. One fill status display can be a simple gauge such as used ina car for gas or a cell phone for battery life.

Referring to FIG. 1, an implantable infusion device 12 having two portassemblies 40, 40′ is shown implanted in a patient. In the presentembodiment, the infusion device 12 is implanted in the side of thepatient's abdomen but may, in other embodiments, be implanted indifferent areas of the body. In one example the infusion device may beimplanted in the pectoralis area or in the buttocks. Of course, infusiondevice 12 may include one, two, three, or any number of port assemblies.

As shown in FIG. 1, a catheter 34 is connected to infusion device 12.Distal portion 99 of catheter 34 may include one or more openingsthrough which fluid can flow and may be positioned at or near a targetlocation to deliver fluid from infusion device 12 to target location.The target area depicted in FIG. 1 is the patient's spinal canal.However, it will be understood that any region of a patient's body mayserve as a target area depending on the conditions, disease, or disorderto be treated. Port assemblies 40, 40′ can be accessed percutaneously bya needle (not shown in FIG. 1), through which fluid may be delivered toinfusion device 12.

Infusion device 12 may be any device capable of delivering fluid to apatient. For example, infusion device 12 may be an access port, e.g. avascular access port, through which bolus injections are deliveredthrough a catheter to a patient. Infusion device 12 may also be a devicehaving a reservoir for holding solutions containing therapeuticsubstances to be delivered over a period of time. Devices that delivertherapeutic substances over time may contain fixed or variable ratepumps, programmable pumps, or the like. An infusion device 12 having areservoir will generally include a port assembly to allow for refillingof the reservoir.

The infusion device 12 shown in FIG. 1 has two port assemblies 40 and40′, one of which may be a catheter access port 40′ and one of which maybe a reservoir fill port 40. One exemplary device having a catheteraccess port and a reservoir refill port is Medtronic's SynchroMed® IIimplantable infusion device (Medtronic, Inc., Minneapolis, Minn.). Inaddition, virtually any other currently known or future developedimplantable infusion device can also be used in connection withprinciples described herein.

While the discussion presented herein is primarily directed to infusiondevices for delivering therapeutic substances to a patient, it will berecognized that the principles described herein may be advantageouslyapplied to a variety of devices that include fluid reservoirs.

Referring to FIGS. 2-8, various embodiments of systems and componentsthereof are shown in block form. FIG. 2 refers to a representativesystem 10 that includes an implantable infusion device 12, a pressuresensor 14, and an indicator device 16. The indicator device 16 may belocated in the infusion device 12 as shown but may also be placed in anexternal programmer, as further discussed below. Also depicted in FIG. 2is a syringe assembly 18 including a needle 20 useful for percutaneouslyinterfacing with the implantable infusion device 12. Infusion device 12shown in FIG. 2 may include a housing 30 that maintains a reservoir 32.Reservoir 32 is designed to contain a therapeutic substance to bedelivered to the patient, for example, via a catheter 34. The reservoir32 may be a constant pressure reservoir, such as a bellows, and may befitted with an over pressure mechanism (not shown) that disrupts andshuts off the in-flow if the pressure exceeds a pre-determinedthreshold.

The therapeutic substance can be any infusion agent, product, orsubstance intended to have a therapeutic effect such as pharmaceuticalcompositions, genetic materials, biologics, and others (e.g., insulin,saline solution, fluoroscopy agents, etc.), Regardless, a pump and/ormetering device (or “flow regulator”) (not shown) can be provided fordictating a flow of the therapeutic substance from reservoir 32 in adesired fashion. The pump/metering device can assume a variety of forms,and device 12 can further include a propellant chamber (not shown)associated with reservoir 32 for maintaining a constant desired pressurein the reservoir 32 to aid in delivering therapeutic substance to theoutlet catheter 34. Other types of pumps may include piston pumps,peristaltic pumps, and others known to those in the art.

In the present embodiment, infusion device 12 may include a fill portassembly 40 fluidly connected to, and otherwise defining an inlet of,reservoir 32. In more general terms, however, fill port assembly 40 mayassume a conventional configuration whereby a septum 42 seals a portchamber 44 relative to an exterior of the housing 30. Port chamber 44,in turn, is in fluid communication with reservoir 32 (e.g., a permanentfluid connection is established and a valve means is provided thatactuates to selectively fluidly connect port chamber 44 and reservoir32, etc.). Needle 20 may percutaneously deliver a liquid to portassembly 40, and in particular through septum 42 and into port chamber44, as part of a reservoir 32 refilling operation. The therapeuticsubstance may then be pushed to the reservoir 32. In the presentembodiment, the pressure in the reservoir 32 is less than ambientatmospheric pressure and so the needle 20 does not need to be actuatedbut rather the ambient atmospheric pressure initiates and sustains theflow of fluid into the reservoir 32. In further embodiments pressure maybe placed on a plunger of the syringe and therefore a higher pressuremay be exerted on the reservoir.

Referring to FIG. 3, an infusion device 12 without a reservoir is shown.In the embodiment shown in FIG. 3, as with the embodiment depicted inFIG. 2, port chamber 44, defined by port assembly 40, is accessible byneedle 20 through septum 42. Port chamber 44 is in fluid communicationwith catheter 34 such that therapeutic substance infused through needle20 into port chamber 44 will be delivered directly to a target area of apatient through catheter 34. Such a system may allow for a bolus oftherapeutic substance to be directly administered.

Regardless of the embodiment depicted, infusion device 12 may includeadditional components as known conventionally or developed in thefuture. For example, infusion device 12 can include a controller 46 orother electronics, for example, in the form of a digital microprocessor,although any equivalent device may be substituted for a digitalmicroprocessor; in many instances, it may also be desirable that thecontroller 46 includes data storage capabilities. Where provided, thecontroller 46 (as well as other components) can be powered by a powersupply 48 (that may be preferably in the form of a battery or otherself-contained power source). Other components can further be providedwith infusion device 12 that are not otherwise illustrated, such assafety valves, flow restrictors, etc., that may enhance operation of theinfusion device 12.

With the above general construction of the infusion device 12 in mind, apressure sensor 14 may be maintained by housing 30, and may be operablysituated between port assembly 40 and reservoir 32 (see, e.g., FIG. 4).The pressure sensor may detect pressure changes in between the chamber44 and the reservoir 32. In further embodiments, pressure changes may bedetected in reservoir 32. In various embodiments, pressure sensor 14sends pressure-related information to a detector circuit 50 that in turnmay prompt operation of an indicator device 16 (see further descriptionbelow).

As depicted in the embodiments shown in FIGS. 2-4, detector circuit 50and indicator device 16 may be included in housing 30. Detector circuit50 may be adapted or programmed to prompt operation of indicator device16 based upon pressure-related information generated and signaled bypressure sensor 14. For example, detector circuit 50 can be configuredor programmed to prompt operation of indicator device 16 upondetermining (e.g., using a logic circuit, a comparator, software etc.)that the pressure sensed by the pressure sensor 14 (or as otherwiseindicated by information signaled from the pressure sensor 14) isindicative of fluid being withdrawn or added to the reservoir 32. Inaddition, the pressure sensed by the pressure sensor 14 may beinterpreted by the detector circuit 50 as indicating the reservoir 32 isempty or full. In further embodiments, the information from the pressuresensor 14 may be further utilized to calculate the fill status of thereservoir 32. The fill status may also be known as the reservoir volume,the fill state, the reservoir level, or by other names, each indicatingthe volume of liquid present in the reservoir. In the embodiments shownin FIGS. 2-4, detector circuit 50 is shown as being a component apartfrom controller 46. In other embodiments, however, detector circuit 50and logic circuit 50 a can be provided with the controller 46 such thatthe controller 46 is programmed to operate indicator device 16 in adesired fashion. With regards to embodiments wherein the reservoirvolume is calculated, indicator device 16 and detector circuit 50 maypreferably be part of an external programmer 62 as discussed below withreference to FIG. 5.

FIG. 5 is a block diagram illustrating a representative system 10 thatis similar in many respects to the system 10 depicted in FIG. 2.However, with the embodiment depicted in FIG. 5, indicator device 60,detector circuit 50, and telemetry circuit 66 are located apart fromhousing 30, for example, as part of an external programmer 62. Externalprogrammer 62 is adapted to communicate with infusion device 12 throughthe patient's skin such that in various embodiments, programmer 62 andinfusion device 12 are in wireless communication. Communication may beestablished via telemetry circuitry 64 maintained by the housing 30 andcorresponding telemetry circuitry 66 maintained by the externalprogrammer 62 (or a component (e.g., a hand-held instrument)electronically coupled to external programmer 62). Alternatively, otherforms of wireless or wired communicative links between infusion device12 and external programmer 62 can be provided.

In various embodiments, pressure sensor 14 is electronically coupled totelemetry circuitry 64 (for example, via a controller (not shown)), withpressure-related information generated by pressure sensor 14 signaled inreal time or near real time to external programmer 62. Externalprogrammer 62 may run the calculations in a variety of different ways,including through software, the detector circuit 50, other hardware,firmware, or some combination, that interprets and then displays theinformation collected by the pressure sensor 14.

The parameters under which detector circuit 50 will prompt operation ofthe indicator device 60 are described in greater detail below. In oneembodiment, indicator device 60 is a display screen adapted to displayinformation to the clinician. As is known in the art, a display screenis commonly provided with an external programmer 62 (e.g., an N′Vision™Programmer available from Medtronic as part of the SynchroMed® IIInfusion System), and can display information in a variety of fashions,for example, with text, pictures, symbols, graphical information, etc.Indicator device 60 can further include a sensory cue generator, such asa sound generator. In one embodiment, upon determining thatpressure-related information generated by pressure sensor 14 isindicative of some flow state of the therapeutic substance, detectorcircuit 50 prompts indicator device 60 to inform the clinician the fillstatus and flow status via the display screen, sound generating device,or the like. Screens indicating the fill status are further discussedbelow.

With the above description in mind, FIGS. 6-8 show alternativeembodiments of system 10 in block form. While FIGS. 6-8 do not show someof the features of the devices described in FIGS. 2-5, it will beunderstood that one or more of the features discussed above may beincluded in various embodiments. System 10 as shown in FIGS, 6-8 mayinclude two port assemblies 40, 40′. Port assembly 40 is a refill portassembly in fluid communication with reservoir 32, and port assembly 40′is a catheter access port assembly in fluid communication with catheter34. Pressure sensor 14, 14′ may be in fluid communication with fill portchamber 44 (FIG. 6), or the catheter access port chamber 44′ (FIG. 7).The pressure sensor 14′ may also be in direct fluid communication withthe fill port chamber 44 and catheter access port chamber 44′ (FIG. 8)or in communication with the passage connecting the fill port chamber 44or catheter access port chamber 44′ with the reservoir 32 or thecatheter 34 (not shown). In addition, the pressure sensor 14, 14′ may bein any portion of the infusion pump 12 so as to enable detection of apressure indicative of a fluid status.

FIG. 9 is a simplified, cross-sectional view of an embodiment of aportion of system 10, such as the pressure sensor 14 in conjunction withrelevant portions of the infusion device 12, such as housing 30,reservoir 32, and the port assembly 40. In general terms, port assembly40 is formed in an opening 70 of housing 30 such that port assembly 40is exteriorly accessible relative to housing 30. Septum 42 is disposedacross port chamber 44 (referenced generally) defined by a wall of portassembly 40, such that septum 42 seals the opening 70 relative to theport chamber 44/reservoir 32. Septum 42 can be manufactured of anysuitable material or materials. Typically, septum 42 will be made ofelastomeric materials, for example, silicone rubber, that are pierceableby needle 20 (which itself does not necessarily form a part of thesystem 10) and compatible with the therapeutic substance (not shown) tobe contained with reservoir 32.

In various embodiments, port assembly 40 may further include a septumplug 74 used to retain septum 42 while providing a fluid-tight seal.Septum plug 74 may define the port chamber 44 to include drain holes 78that allow fluids delivered to port chamber 44 to pass into reservoir32. In some embodiments, a valve feature (not shown) can be provided tofurther control flow of liquid from port chamber 44 to reservoir 32 asis known in the art. In still further embodiments the drain holes 78 maylead to a passage (not shown) that then leads to the reservoir 32. Theseptum 42 may define a first exterior side 80 and a second or inferiorside 82. Exterior side 80 is exposed relative to opening 70 of housing30, whereas interior side 82 defines a portion of port chamber 44. WhileFIG. 9 is described with regard to a fill port assembly 40, it will beunderstood the components described with regard to FIG. 9 can be readilyapplied or adapted to the catheter access port assembly.

With the above conventions in mind, pressure sensor 14 may, in variousembodiments, be associated with port assembly 40, and in particular portchamber 44, by placing the pressure sensor 14 along an interior of awall of septum plug 74. In other embodiments, pressure sensor 14 may bedisposed within a thickness of septum plug 74 (such as by forming (e.g.,overmolding) septum plug 74 about pressure sensor 14). Even further,pressure sensor 14 may be assembled to an exterior of septum plug 74(relative to the port chamber 44). In further embodiments the pressuresensor 14 is placed in the drain holes 78 or in the passage that leadsto the reservoir 32 from the port assembly 40.

Pressure sensor 14 may be in a variety of different forms. For example,pressure sensor 14 may be a capacitive measurement device whichdetermines pressure by measuring the change in capacitance of a flexiblemembrane attached but insulated from a conductive, gas-filled cavity dueto deflections caused by pressure applied over the flexible membrane.Alternatively, pressure sensor 14 may be a sensor that utilizes thepiezo-electric effect or resistive change due to metallic strain inorder to measure pressure applied. Regardless of the specific manner inwhich pressure sensor 14 measures pressure, in various embodiments,pressure sensor 14 is adapted to generate a signal indicative of apressure of port chamber 44. Alternatively, pressure sensor 14 may beadapted to generate a signal indicative of a change in pressure of portchamber 44. Pressure sensor 14 may be any device capable of sensing andsignaling information indicative of pressure characteristics associatedwith port chamber 44 or the passage between the port chamber 44 and thereservoir 32. Pressure sensor 14 may be electronically coupled todetector circuit 50 or indicator device 16, in a variety of ways. Forexample, electrical wiring (not shown) can provide the desiredelectrical connection. Alternatively, a wireless link may be providedbetween pressure sensor 14 and the processing device and/or displaydevice selected.

In general terms and without being bound by the following description,it is believed that withdrawal or filling of therapeutic substance fromthe reservoir 32 causes the pressure profile existing in the fluidsystem to fluctuate from a normal state. In addition, when the reservoir32 reaches an empty or full state, or a substantially empty or fullstate, or when the needle 20 is inserted or when clamps are opened andclosed, the pressure profile may also change. Utilization of thepressure information may provide the user with reservoir fill statusinformation and allow for a gauge to be displayed that indicates theapproximate fill level of the reservoir during filling, emptying andpumping procedures, as is further discussed above.

Referring to FIG. 10, an exemplary pressure profile of withdrawing fluidfrom the reservoir 32 and then adding fluid to the reservoir 32 will bedescribed. Withdrawal may be undertaken when the therapeutic substancekept in the reservoir 32 is being removed. Afterward the reservoir 32can be filled with the newly selected therapeutic substance. In somecases this may be the same therapeutic substance at a differentconcentration. In other cases it may be a different drug. In stillfurther situations the reservoir 32 may first be rinsed with a differentmaterial before the new therapeutic substance is placed therein. Thepressure profile shown in FIG. 10 can be obtained using any of theexample systems 10 described above. Moreover, variations on the pressureprofile may be obtained depending on whether a reservoir 32 is beingaccessed for emptying and/or filling or whether a catheter 34 is beingaccessed for a bolus injection. As described below, the indicatedpressure may indicate a fluid flow status that is indicative of thedirection of the fluid flow and how much fluid is left in the reservoir32 or the port chamber 44.

The pressure profiles depicted in FIG. 10 were obtained by continuouslysampling the pressure of the refill septum port of a prototype,bellows-based reservoir pump over the course of an entire refillprocedure.

The normal pressure indicated by the pressure sensor 14 in the presentembodiment infusion pump 12 is approximately 490 mmHg (about 9.5 poundsper square inch (psi)) as the present embodiment infusion pump 12 is anegative pressure pump wherein the fluid in the reservoir 32 and theport chamber 44 are kept at a pressure below normal atmosphericpressure, normally about 760 mmHg (about 14.7 psi). (The presentinvention, however, is just as applicable to a neutral or positivepressure reservoir pump.) FIG. 10 illustrates the reservoir 32 pressureas approximately 515 mmHg. Position A on the graph shows a pressurespike when the needle 20 is inserted into the port chamber 44. In thepresent embodiment, the needle is connected to a tubing or hose that,during the initial insertion, is clamped off from a needle reservoirinto which the fluid from the reservoir 32 will be drained or from whichthe fluid will be placed into the reservoir 32. Position B indicatesanother pressure spike when the clamp on the tubing separating theneedle 20 from the needle reservoir is unclamped or released. In thepresently described method the needle reservoir is empty and the fluidin the infusion pump 12 reservoir 32 will be removed before new fluidwith a therapeutic substance contained therein is placed in thereservoir 32.

As illustrated at point C, when the syringe is withdrawn to create a lowpressure in the needle reservoir so as to draw the fluid from thereservoir 32, a relatively rapid drop in pressure is detected by thepressure sensor 14. Fluid will begin to flow out of the reservoir 32 andthe port chamber 44 at a steady rate that depends on the degree of lowpressure created in the needle reservoir. Point D on the pressure graphillustrates a pressure decrease during the withdrawal (aspiration) phaseof the fluid from the reservoir 32.

As may be appreciated, the steady state infusion pump 12 reservoir 32will try to compensate and maintain the pre-programmed pressure in thereservoir 32. As the reservoir empties, the pressure will drop, butwithin a specific range as shown at point D. Therefore, the pressurewill slowly drop as shown at point D. However, at some point thereservoir 32 will no longer be able to maintain the pressure as toolittle fluid will remain in the reservoir 32. When the reservoir 32 isat or near an empty state, the reservoir 32 and pressure compensationsystem of the infusion pump 12 may no longer be able to keep an elevatedpressure, and the pressure will quickly drop as illustrated at point E.In the present embodiment the reservoir 32 may undergo the non-linearpressure behavior illustrated in FIG. 10 at point E when at or near theempty state. Point F illustrates the pressure stabilizing in the emptyreservoir 32 and the port chamber 44 at some reduced pressure dependingon the relative low pressure being exerted by the syringe. At point Fthe tubing is clamped for removal of the first syringe and connection ofa refill syringe to the tubing.

Point G illustrates a relatively slow increase in the detected pressuretowards the nominal pressure after the reservoir 32 is emptied and thetubing has been clamped. The increase in the detected pressure may be inpart due to the inability of the pump to perfectly hold a vacuum. Microamounts of gas may permeate through the septum.

Point I illustrates where the tubing is unclamped such that the pressurefrom the refill syringe containing fluid for filling the reservoir 32 istransferred to port chamber 44 and reservoir 32 and is detected by thepressure sensor 14. At point J a rapid rise in pressure is shown. In thepresent embodiment, the pressure in the fluid in the refill syringe isat atmospheric pressure. The pressure inside the reservoir 32 is setbelow this and so as the atmospheric pressure (760 mmHg) of the fluidenters the reservoir 32 the reservoir 32 tries to compensate and returnto the lower selected pressure. Point K shows the reservoir 32 andpropellant equalizing the pressure back to the predetermined set state.However, in the present embodiment the pressure may slowly rise such asat point L as the reservoir 32 is filled. As may be appreciated, ifpressure were to be applied to a syringe plunger to increase the flowrate into the infusion pump 12, the pressure exerted may besignificantly higher.

In the present embodiment, when the reservoir 32 has expanded to such apoint wherein the pressure in the reservoir 32 exceeds somepredetermined level, an over pressure mechanism may engage to stop theflow of fluid into the reservoir 32. Point M shows the pressure spike asthe reservoir reaches a full state. Point N is the point at which theclamp on the tubing is reset. The pressure detected may then fall againas the reservoir continues to work to adjust the internal pressure tothe set level. Point P shows where the needle 20 is removed and thefilling operation is complete.

As can be seen from FIG. 10, during filling of the reservoir 32, anincrease in pressure is observed. Again, because in the presentembodiment the pump is a constant pressure pump, the reservoir 32 andpropellant gases will try to compensate by reducing the pressure placedon the reservoir 32. However, there will still be a measurable increasein pressure during the time in which the reservoir 32 is being filleddue to the compensation lag. As previously mentioned, the presentembodiment is used with a constant pressure reservoir. One example ofsuch a reservoir includes an accordion shaped reservoir body (which maybe described as a bellows shape) surrounded by propellant gasses thatkeep the pressure inside the reservoir 32 constant. However, somepressure differentiation, i.e., higher or lower pressure, will occur asfluid is withdrawn as the propellant gases try to “catch up” thereservoir 32 to the pre-set reservoir 32 pressure. This may result indifferent pressure profiles depending on the type of system. However,still detectable pressure changes may still be indicative of fluid flowstatus.

Reservoir Fluid Volume

FIG. 11 illustrates a screen 299 for reporting information on theexternal programmer 62 indicator device 60 to the user. In the presentscreen 299 the needle 20 has been detected in the reservoir fill port40. Screen 299 reports at 300 that the needle 20 is detected in thereservoir. (Such an indication may be actually indicative that theneedle 20 has pierced the septum 42 and entered the chamber 44.) As maybe appreciated, various combinations of verbiage and visual indicatorscan be utilized and combined to indicate the presence of the needle 20.Screen 299 further shows a gauge 304 for reporting the fill status 308of the reservoir 32.

The fill status 308 shown on the gauge 304 will be the amount of fluidthat is present in the reservoir 32. The gauge 304 may also be called aninstrument, a fluid indicator, a fluid meter, or other names. At screen299 the gauge 304 is not yet reporting the fill level of the reservoir32. Methods of determining the fill status 308 are discussed furtherherein.

In this illustration, screen 299 also reports at 302 that the externalprogrammer 62 is in communication to the infusion device 12. If thecommunication were to be lost, the bar may disappear or other screensmay appear as further discussed below. As may be appreciated, reportingthe communication connection between the programmer 62 and the infusiondevice 12 may be represented in a number of different ways.

FIG. 12 illustrates screen 301 (similar to FIG. 11) wherein the gauge304 reports a fill status 308 and a filling operation. The pressuresensor 14 has detected an increase in pressure and, when the informationis transferred to the programmer 62, software in the programmer 62interprets that information as a filling operation. In the presentembodiment the screen utilizes the word “Filling” and an up arrowsuperimposed on gauge 304 to report that a filling operation isoccurring. In alternative embodiments a variety of words and visualindicators may be mixed and matched to report this information.

Screen 301 as shown may also report the fill status 308 of the reservoir32 on gauge 304. The fill status 308 is an indication of how much fluidis present in the reservoir 32. In the present embodiment, the fillstatus 308 is shown as a curve. In alternative embodiments, the fillstatus 308 can be shown utilizing bars, numbers, a dial, or with othergraphics. The gauge 304 may or may not include units to report the fillstatus 308. In the present embodiment only a relative fill status 308 isdisplayed without units.

The fill status 308 may be based upon several pieces of information.Initially, the fill status 308 may be based on the reservoir 32 beingfilled after the infusion device 12 is first implanted. Programmer 62can then start a continuous count of the amount of fluid in thereservoir 32 based on the total the reservoir 32 volume and the amountof fluid pumped from the reservoir 32. The programmer 62 can performthis and the other functions described herein using software, hardware,or some combination. Further, the calculations and other functions canbe done in infusion pump 12 or in the programmer 62.

To determine the volume of fluid present in the reservoir 32, the numberof pump strokes since the last reservoir 32 full state can be used todetermine the amount of fluid pumped. This calculation may be based uponthe known volume of fluid pumped per stroke. Alternatively, the amountof fluid pumped since the reservoir 32 was last full, based on theprogrammed rates and times, may also be utilized. Because the infusiondevice 12 has been programmed to deliver a certain amount of fluid overa certain period of time, whether in a constant dosing pattern or in aflex pattern, the fill status 308 of the infusion device 12 can becalculated with reasonable accuracy. In either case, this amount can beused to calculate the relative fill status 308 of the reservoir 32 fordisplay on the gauge 304 when the infusion device 12 is contacted by theprogrammer 62 during refill or other procedures. As may be appreciated,such a calculation assumes operational connectivity between thecontroller 62 and implant pump 12 for the reporting of the pump strokeand reservoir 32 capacity data. The method of determining the estimatedfill status 308 during filling or aspirating of the reservoir 32 isfurther discussed below

Screen 303 shown in FIG. 13 includes the same features as previouslydescribed but reports at 306 that the reservoir 32 is being emptied offluid. The removal of fluid from the reservoir 32 is reported by theword “Emptying” and a down arrow. As previously suggested, alternativewords or symbols could be utilized to report this information. Inaddition, various colors may be integrated into screen 303 to helpindicate the filling or emptying status.

FIG. 14 illustrates screen 305 for use in providing additionalinformation during other operations. Screen 305 indicates at 310 thatthe needle has been detected in the catheter access port 40′ (portassembly 40′). Also illustrated is an indication that the fluid in thecatheter access port 40′ is being withdrawn (aspirating) at 312.Alternatively, the fluid can be reported as being injected (injecting)at 314. The fluid may be aspirated from the catheter access port 40′ inorder to take a sample of the fluid in which the end of the catheter isimplanted, such as the cerebrospinal fluid, or to withdraw the fluidbefore placing another fluid therein (injecting), such as a contrastdye.

FIG. 15 illustrates screen 307 which reports at 316 that the needle isdetected in the catheter access port 40′. Screen 307 may also include awarning indicator at 318. Such a warning may be utilized when the useris performing a filling operation intended to insert fluid into therefill port assembly 40 and not the catheter access port 40′. Thewarning may indicate to the user that the syringe 20 has been placedthrough the wrong septum

FIGS. 16-18 are representative screens 309, 311, and 313, respectively,that show further warnings that may be given in various situationsdepending on the information detected by the pressure sensor 14 and theinterpretation by the software of that information. Screen 309illustrates when the communication between the infusion device 12 andthe external programmer 62, illustrated previously at 302, has beeninterrupted. Such a warning may be displayed at 320 with an illustrationand at 322 with words.

Screen 311 may indicate at 324 that no activity has been detected for aset period of time. Screen 311 may be utilized after the needle 20 hasbeen detected in either port assembly 40, 40′. Pressure sensor 14 shouldnormally detect when the needle 20 is moved or used during a filling oremptying operation. If no further activity is detected for a set periodof time during filling or emptying the system indicates that no activityhas been detected. Screen 311 will help to indicate to the user that theneedle 20 has not been moving. If the user has not been moving theneedle 20, the warning can simply be cleared. In other situations, thefailure to detect movement might be indicative of another problem, suchas dislodgement of the needle from the septum. A symbol as illustratedat 326 may be an additional indicator.

Screen 313 illustrates a notice at 330 to tap the needle to verify thatthe needle is still properly placed in the port assembly 40, 40′.Tapping the needle 20 will provide a pressure variation that should bedetected by pressure sensor 14 to indicate that the needle 20 is stillproperly placed.

Volume Calculation

The total volume of fluid in the reservoir 32, or fill status 308, maybe calculated for reporting on gauge 304. In one method, the calculationwill rely on the reservoir 32 starting in a full or empty state. Such astate may exist after the infusion device 12 is first implanted (empty)or first filled (full). For example, if the reservoir 32 is empty, thecalculations can be undertaken based upon a zero volume fluid state.

FIG. 19 illustrates an ideal curve of pressure versus volume for thereservoir 32. While FIG. 19 does not illustrate the pressure that wouldoccur during a filling or emptying operation (see FIG. 10), FIG. 19illustrates at curve 404 what the pressure would be at various periodsbased upon the reservoir 32 fill status 308 if the reservoir 32 wereable to maintain the ideal pressure at each fluid volume. The flat partof curve 404 shows where the reservoir 32 operates at the normaloperating pressure and the propellant gases are able to compensate forthe changing fluid status 308 (fluid volume) to maintain the pressureset point. Range 406 between the dashed lines, at a pressure above andbelow 404, illustrates an operating range that could be designated asnormal or acceptable but as a departure from ideal.

Of particular note are the end points of curve 404 and when thereservoir 32 starts to report lower or higher than normal pressures.During the range indicated by 400, for example, is when the pressure inthe reservoir 32 goes to a level below the ideal operating range (thepoint depending on the size of the reservoir 32 and other factors). Sucha situation may occur when the volume of fluid in the reservoir 12 is solow that the reservoir 32 may not be able to compensate and maintain thepre-programmed pressure. At this point the pressure detected by thepressure sensor 14 reaches a point designated as the empty detectedpressure threshold. The empty detected pressure threshold is that pointat which the software tracking the reservoir 32 volume is able to resetsthe volume of fluid present in the reservoir 32, for purposes ofdisplaying on gauge 304, to zero. The empty detected pressure thresholdpoint on curve 404 may also be designated an empty volume threshold. Inalternative embodiments the empty volume threshold and the emptydetected pressure threshold may or may not be the same point on curve404. While some small amounts of fluid may remain in the reservoir 32,the volume is at a low enough level that it can be considered zerovolume for purposes of calculating the fluid status 308 for display ongauge 304. As also illustrated, at some reservoir 32 fluid volume higherthan the empty detected pressure threshold, is an empty maintainedpressure threshold. When the pressure goes above the empty maintainedpressure threshold during refilling the calculation of the fluid status308 begins.

The empty maintained pressure threshold may be higher than the emptydetected pressure threshold because the empty detected pressurethreshold may be reached during peak application of vacuum pressureduring aspiration operations. However, some amount of air may leak backinto reservoir 32 after aspiration that drives the detected pressure,and hence the detected volume, higher. Designating the empty maintainedpressure threshold at some pressure higher than should be reached byresidual air leaking into the reservoir can help to eliminate falsefluid status 308 readings. Designating the detected threshold versus themaintained threshold in this manner is a known method of eliminatingerror in such a measurement operation. With reference to FIG. 10, theempty detected pressure threshold may be between points E and F on thegraph.

A similar situation may occur when the reservoir 32 pressure is abovethe ideal operating range wherein the full detected pressure thresholdis set at some pressure higher than the full maintained pressurethreshold. A full volume threshold may likewise correspond to the pointon curve 404 where the full detected pressure threshold is set.

The thresholds designated for starting the calculation of the fluidstatus 308 may preferably be near enough to a completely empty (or,alternatively, full) state that it provides a reliable starting pointfor determining the fill status 308 using the below describedcalculations. As may be appreciated, the full maintained pressurethreshold will normally be taken into account when calculating thereservoir fill status 308 during the initial sages of a refillprocedure. The amount of fluid pumped since the last time the reservoir32 was at the full maintained pressure threshold, calculated in a manneras previously described, will be utilized to indicate the approximatefluid status 308 after the infusion device 12 has been pumping for sometime. In other words, for calculating the starting point of reservoirvolume when the pump is being aspirated before filling. Because thereservoir 32 may be normally fully aspirated as an initial step in arefill procedure, the empty volume threshold will then be utilized tostart the calculations of fill status 308 for filling. In alternativeembodiments, the reservoir 32 may be filled from a partially filledstate. In still further embodiments the reservoir 32 may be rinsed oneor more times before a new drug or a new concentration of the drug isplaced into the reservoir, resulting in one or more full or empty statesfrom which the software may calculate the fill status 308.

In one method, the volume added or removed from reservoir 32 may becalculated by using the starting volume of fluid in the reservoir 32 andthen adding or subtracting the volume added or removed from thereservoir. The volume added or removed from the reservoir may bedetermined by integrating the fluid rate over time:

Vol._fill = ∫_(start)^(end)fluid_rate t

In one embodiment the fluid rate may be determined by taking the rate ofchange of the pressure over time during the filling or emptying of thereservoir 32. The rate of change may be directly proportional to thefluid rate. As illustrated in FIG. 10, the slope of the graph at regionD is the rate of change of the pressure over time during aspiration.Likewise, the slope at region L is illustrative of the rate of change ofthe pressure over time when the reservoir 32 is being filled. Thesoftware may calculate the slope in real time or near real time basedupon the information transmitted to the programmer 62 through thetelemetry circuit 64. The slope is then used to determine the fluidrate.

In another embodiment, the fluid rate may be determined by measuring thepressure differential between the reservoir 32 and the port 40 utilizingthe pressure sensor 14. The pressure measured by the pressure sensor 14may be positive for filling and negative for emptying, due to theinsertion or extraction of fluid from the port 40, respectively. Therate of fluid being inserted into the reservoir 32 or extracted from thereservoir 32 is then calculated utilizing a known fluidic restrictionconstant and the formula:

Fluid Rate=Pressure Differential/Fluidic Restriction

The fluidic restriction is a known constant based upon the flowrestrictions of the pump and can be measured or calculated for the pumpbefore implantation. If the reservoir 32 starts out at an empty volume,the fill status 308 can then be calculated based on the fill rate andthe known starting point. In other situations, the fill status at thestart of the operation may be full or at some point between empty andfull. As may be appreciated, the fill status 308 can be continuallycalculated as the volume in reservoir 32 goes up and down. In thepresent embodiment, the calculated fill status 308 can be reset to fullor empty every time the reservoir 32 reaches the full volume thresholdor the empty volume threshold.

FIG. 20 illustrates one example of an estimated (calculated) reservoir32 fill status 308 over time. The fluid flow rate is integrated over thefilling time to produce the fluid status displayed in the graph for a 20mL reservoir 32. The curve illustrated in FIG. 20 roughly corresponds tothe (ideal) pressure curve of FIG. 19 wherein the low fluid volume isequal to low pressure in the reservoir 32 and high fluid volume is equalto high pressure in the reservoir 32. FIG. 20 is a representative curvebut may closely resemble calculated levels achieved over time that wouldbe displayed on the gauge 304 illustrated in, for example, FIG. 11.

FIG. 21 illustrates a flow diagram illustrating a method of determiningand displaying the fill status of the reservoir gauge. This method maybe utilized with a variety of different procedures, such as inserting aneedle in the catheter access port or in the fill port assembly, but ispresently described for inserting the needle into the fill port assemblyto inject fluid into the reservoir. The reservoir I in the empty stateto start but in other embodiments may be at any level at the start.First, the refill needle and syringe are prepared (500). The needle isthen inserted through the septum and into the port assembly (502). Thepressure sensor detects (504) the needle and then detects fluid flowbased on the pressure differential (506). The fact that a fillingoperation is occurring can then be reported to the user (508). The logiccircuit may then utilize the pressure differential determined bypressure sensor to calculate the fluid flow rate (510) and the fluidvolume/fluid status (512) based on the flow rate and the known startingfluid volume/status (in this case empty). The fluid volume/status maythen be reported to the user (514). The operation of detecting the fluidpressure through reporting the fluid volume/status to the user may berepeated and the gauge updated as long as the pressure sensor continuesto detect fluid flow. Once the reservoir is full or empty, or the userstops injecting fluid such that the pressure sensor no longer detectsfluid flow, the operation is complete (516). In addition, if needleslips out of the fluid flow would stop and the gauge would not beupdated, even if the user is still injecting fluid.

In alternative embodiments the needle and syringe may be utilized in thecatheter access port, the needle may be utilized to first aspirate thereservoir, or the needle and syringe may be utilized to clean thereservoir and infusion pump. As may be appreciated, a variety of changesmay be made to the method without departing from the spirit and scope ofdetecting fluid flow, determining a fluid state, and displaying thefluid state to the user.

One of skill in the art will understand that components or stepsdescribed herein regarding a given embodiment or set of embodiments mayreadily be omitted, substituted, or added from, with, or to componentsor steps of other embodiments or sets of embodiments, as appropriate ordesirable.

1-11. (canceled)
 12. An implantable infusion device comprising: ahousing; a port assembly defining a port chamber, the port assemblybeing disposed in the housing such that the chamber is accessible by aneedle inserted through the exterior of the housing; a re-fillablereservoir in communication with the port chamber; a pressure sensor influid communication with the port chamber and configured to sense a rateof change of pressure as fluid is added to the reservoir via the portchamber; and electronics disposed in the housing and operably coupled tothe pressure sensor, the electronics configured to determine a fluidflow rate into the reservoir based on the rate of change of thepressure, determine a total volume of fluid added to the reservoir byintegrating the fluid flow rate over the time when fluid is added to thereservoir, and combining the total volume of fluid added to thereservoir with a known starting volume of fluid in the reservoir todetermine a volume of fluid in the reservoir during the refillprocedure.
 13. The implantable infusion device of claim 12, wherein thepressure sensor is in the reservoir.
 14. The implantable infusion deviceof claim 12, wherein the pressure sensor is upstream of the reservoir.15. The implantable infusion device of claim 14, wherein the electronicsare configured to calculate the reservoir pressure based on a knownfluidic restriction between the upstream pressure sensor and thereservoir.
 16. The implantable infusion device of claim 12, wherein theelectronics are further configured to determine the known startingvolume by subtracting the fluid volume pumped from the implantablemedical device since the last time point at which the reservoir wasfull.
 17. The implantable infusion device of claim 16, wherein theelectronics are configured to determine the volume pumped from theimplantable medical device by multiplying the number of strokes of thepump by the volume of fluid pumped per stroke.
 18. The implantableinfusion device of claim 12, wherein the electronics are furtherconfigured to determine a fluid flow rate out of the reservoir based onthe rate of change of the pressure when fluid is removed from thereservoir via the port chamber.
 19. The implantable infusion device ofclaim 18, wherein the electronics are further configured to determine atotal volume of fluid removed from the reservoir via the port chamber byintegrating the fluid flow rate over the time when fluid is removed fromthe reservoir via the port chamber.
 20. An implantable infusion devicecomprising: a housing; a port assembly defining a port chamber, the portassembly being disposed in the housing such that the chamber isaccessible by a needle inserted through the exterior of the housing; are-fillable reservoir in communication with the port chamber; a pressuresensor in fluid communication with the port chamber and configured tosense a rate of change of pressure as fluid is added to the reservoirvia the port chamber; and electronics disposed in the housing andoperably coupled to the pressure sensor, the electronics configured todetermine a fluid flow rate out of the reservoir based on the rate ofchange of the pressure, determine a total volume of fluid removed fromthe reservoir by integrating the fluid flow rate over the time whenfluid is removed from the reservoir, and subtracting the total volume offluid removed from the reservoir from a known starting volume of fluidin the reservoir to determine a volume of fluid in the reservoir. 21.The implantable infusion device of claim 20, wherein the electronics arefurther configured to determine the known starting volume by subtractingthe fluid volume pumped from the implantable medical device since thelast time point at which the reservoir was full.
 22. The implantableinfusion device of claim 21, wherein the electronics are configured todetermine the volume pumped from the implantable medical device bymultiplying the number of strokes of the pump by the volume of fluidpumped per stroke.
 23. A method for calculating a fill status of areservoir in an implantable medical device during a procedure to refillthe reservoir, the method comprising: sensing a pressure differentialbetween the reservoir and a fill port using a pressure sensor as fluidis introduced into the reservoir via the fill port; determining a rateof change of the pressure differential as the fluid is introduced intothe reservoir; determining a fluid rate at which the fluid is introducedto the reservoir based upon the rate of change of the pressuredifferential and a known fluidic constant for the medical device;determining a total volume of fluid added to the reservoir byintegrating the fluid rate over the time in which fluid is introducedinto the reservoir; and combining the total volume of fluid added to—thereservoir with a known starting volume of the reservoir to determine thefill status.
 24. The method of claim 23 further comprising: determininga rate of change of the pressure as fluid is removed from the reservoirvia the fill port assembly in fluid communication with the reservoir;determining a fluid flow rate out of the reservoir based on the rate ofchange of the pressure; determining a total volume of fluid removed fromthe reservoir by integrating the fluid flow rate over the time in whichthe pressure is sensed using the pressure sensor; and combining thetotal volume of fluid removed from the reservoir with the known startingvolume of fluid in the reservoir to determine the volume of fluid in thereservoir.
 25. The method of claim 23, wherein combining the fluidvolume added to the reservoir with the known starting volume of fluid inthe reservoir is performed by a logic circuit.